Endoscope with low-profile distal section

ABSTRACT

An endoscope can comprise a proximal section, an insertion section extending longitudinally from the proximal section and comprising an elongate tubular body disposed along an insertion section longitudinal axis and a lumen extending through the elongate tubular body, and a distal section extending from the insertion section and comprising an elevator portion comprising an elevator configured to position and orient one or more endotherapy tools extending from the lumen, and a camera module comprising an illumination unit and an imaging unit. The camera module can be positioned longitudinally spaced apart from the elevator portion in an in-line configuration, such that the insertion tube longitudinal axis passes through the elevator portion and the camera module. The camera module can be user-detachable from the elevator portion. The camera module can be cleaned and sanitized for reuse and the insertion section can be disposable.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority to U.S.Provisional Patent application 62/958,041 filed Jan. 7, 2020, titled“Endoscope with a Low-Profile Distal Section”; U.S. Provisional PatentApplication No. 62/958,782, filed Jan. 9, 2020 titled “Endoscope With AnElevator”; U.S. Provisional Patent Application No. 63/024,674 filed May14, 2020, titled “Endoscope With Low-Profile Distal Section”; and U.S.Provisional Patent Application No. 63/024,682 filed May 14, 2020, titled“One-Piece Elevator For A Duodenoscope”; the entire contents of whichare hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to medical devices comprisingelongate bodies configured to be inserted into incisions or openings inanatomy of a patient to provide diagnostic or treatment operations.

More specifically, the present disclosure relates to endoscopes forimaging and/or providing passage of therapeutic devices toward variousanatomical portions, including gastrointestinal tract (e.g., esophagus,stomach, duodenum, pancreaticobiliary duct, intestines, colon, and thelike), renal area (e.g., kidney(s), ureter, bladder, urethra) and otherinternal organs (e.g., reproductive systems, sinus cavities, submucosalregions, respiratory tract), and the like.

BACKGROUND

Conventional endoscopes can be involved in a variety of clinicalprocedures, including, for example, illuminating, imaging, detecting anddiagnosing one or more disease states, providing fluid delivery (e.g.,saline or other preparations via a fluid channel) toward an anatomicalregion, providing passage (e.g., via a working channel) of one or moretherapeutic devices for sampling or treating an anatomical region, andproviding suction passageways for collecting fluids (e.g., saline orother preparations) and the like.

In conventional endoscopy, the distal portion of the endoscope can beconfigured for supporting and orienting a therapeutic device, such aswith the use of an elevator. However, such distal portions can, in a fewinstances, lead to difficulty in sterilizing or reprocessing the distalportion after use. For example, conventional endoscopy devices can becompletely reusable such that crevices between components or spaceswithin functional components of the distal portion can be difficult toaccess and clean.

SUMMARY

The present inventors have recognized that problems to be solved withconventional medical devices, and in particular endoscopes andduodenoscopes, include, among other things, particularly those that aredifficult or not configured to be easily disassembled, 1) the need anddifficulty of cleaning and sterilizing endoscopes after usage, 2) thecost of maintaining multiple endoscopes in inventory to performdifferent surgical techniques or therapeutic methods on differentpatients, and 3) the cost of purchasing medical devices having excesscapacity or unwanted capabilities for a particular patient. The presentdisclosure can help provide solutions to these and other problems byproviding systems, devices and methods for designing, building, usingand deconstructing modular endoscopes. In particular, the presentapplication is directed to detachable camera modules for medical devicessuch as endoscopes and duodenoscopes. The camera modules can beconfigured for reuse after appropriate cleaning and sterilization, whilethe insertion sheaths and shafts to which they can be configured toconnect can be configured for one-time use. As such, more expensivecamera components can be modularly attached to inexpensive, disposableinsertion sheaths and shafts. Said modular camera components can beconfigured for cleaning, e.g., by being encapsulated, while theinsertion sheath and shafts can be inexpensively made to perform onlythe desired procedure and then disposed of after use. Suchconfigurations can eliminate the need to clean in difficult to reachplaces in fully assembled devices and the need to maintain a largeinventory of devices with different or excess capabilities.

The present inventors have also recognized that problems to be solvedwith conventional medical devices, and in particular endoscopes andduodenoscopes, include, among other things, the complexity of somecomponents that can lead to increased difficulty in cleaning. In orderto avoid difficult cleaning processes, it can be desirable to make suchcomponents disposable. As such, it is desirable to make such disposablecomponents less expensive. The present disclosure can help providesolutions to these and other problems by providing systems, devices andmethods comprising an elevator for side viewing duodenoscopes, and otherdevices, that is simple in design and therefore less expensive andeasier to make than conventional elevator mechanisms.

The present inventors have additionally recognized that problems to besolved with conventional side viewing endoscopes, such as duodenoscopes,include, among other things, the increased size of the distal end of thedevice due to the presence of an elevator, which is typically locatednext to, i.e., radially relative to the longitudinal axis of the device,thereby increasing the diameter of the device. Increased size of thedistal end of the device can make it difficult to navigate the devicethrough anatomy of a patient, particularly when faced with small sizedorifices or anatomic passageways that intersect at acute angles. Thepresent disclosure can help provide solutions to these and otherproblems by providing systems, devices and methods comprisingside-viewing endoscopes that position imaging and illumination unitsdistal of the elevator mechanism, thereby allowing for smaller distalends of such medical devices compared to typical duodenoscopes.

In an example, an endoscope can comprise a proximal section, aninsertion section extending longitudinally from the proximal section andcomprising an elongate tubular body disposed along an insertion sectionlongitudinal axis and a lumen extending through the elongate tubularbody, and a distal section extending from the insertion section andcomprising an elevator portion comprising an elevator configured toposition and orient one or more endotherapy tools extending from thelumen, and a camera module comprising an illumination unit and animaging unit, the camera module being positioned longitudinally spacedapart from the elevator portion in an in-line configuration, such thatthe insertion tube longitudinal axis passes through the elevator portionand the camera module.

In another example, an endoscope can comprise a proximal section, aninsertion section extending longitudinally from the proximal section andcomprising an elongate tubular body disposed along an insertion sectionlongitudinal axis, and a lumen extending through the elongate tubularbody, and a distal section extending from the insertion section andcomprising an elevator portion comprising an elevator configured toposition and orient one or more endotherapy tools extending from thelumen, and a camera module comprising an illumination unit and animaging unit, the camera module being user-detachable from the elevatorportion.

In an additional example, a method of processing modular endoscopecomponents for performing a surgical procedure can comprise identifyinga specific patient to receive a specific treatment, selecting aninsertion sheath to deliver the specific treatment, attaching a cameramodule to the insertion sheath, treating the specific patient with theinsertion sheath having the attached camera module, and deconstructingthe components of the modular endoscope into reusable and disposablecomponents.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic diagram of an endoscopy system comprising animaging and control system and an endoscope, such as duodenoscope.

FIG. 2 is a schematic diagram of the endoscopy system of FIG. 1comprising the endoscope connected to a control unit of the imaging andcontrol system.

FIG. 3 is a schematic top view of a camera module including opticalcomponents for a side-viewing endoscope.

FIG. 4 is an enlarged cross-sectional view taken at plane 4-4 of FIG. 3showing the optical components.

FIG. 5 is a schematic view of a modular endoscope suitable for use asthe endoscope of FIGS. 1-4 comprising a camera module, an insertionsection module, and a navigation and control module that are configuredto be detachable from each other.

FIG. 6A is a schematic view of a first example of a low-profile,side-viewing, endoscope of the present disclosure comprisingside-by-side illumination and imaging units relative to an elevatorportion.

FIG. 6B is a schematic cross-sectional view of the endoscope of FIG. 6Ataken at plane 6B-6B showing illumination and imaging unit passagewayslocated aside an insertion passageway.

FIG. 7A is a schematic view of a second example of a low-profile,side-viewing endoscope of the present disclosure comprising end-to-endillumination and imaging units relative to an elevator portion.

FIG. 7B is a schematic cross-sectional view of the endoscope of FIG. 7Ataken at plane 7B-7B showing illumination and imaging unit passagewaysaligned with an insertion passageway.

FIG. 8 is a schematic cross-sectional view of the low-profile,side-viewing endoscope of FIG. 6A taken at plane 8-8 showing the imagingunit and the imaging passageway relative to the elevator.

FIG. 9 is a schematic cross-sectional view of the low-profile,side-viewing endoscope of FIG. 6A taken at plane 9-9 showing theillumination unit and the illumination passageway relative to theelevator.

FIG. 10 is a schematic illustration of a distal portion of an endoscopeof the present disclosure including an attachment mechanism fordetachable camera module.

FIG. 11 is a schematic illustration of a distal portion of an endoscopeof the present disclosure including a wide-angle lens.

FIG. 12 is a schematic cross-sectional view of the distal portion of theendoscope of FIG. 11 taken at plane 12-12 showing a profile of thewide-angle lens.

FIG. 13 is a perspective view of an elevator mechanism of the presentdisclosure suitable for use with disposable, low-profile endoscopes.

FIG. 14 is a top view of the elevator mechanism of FIG. 13 in aflattened state.

FIG. 15 is a side cross-sectional view of the elevator mechanism of FIG.13 taken at plane 13-13 showing an instrument guide flange.

FIG. 16 is schematic cross-sectional view of the elevator mechanism ofFIG. 13 showing an instrument located in an insertion passagewayretracted from the elevator mechanism.

FIG. 17 is schematic cross-sectional view of the elevator mechanism ofFIG. 14 showing the instrument advanced through the insertion passagewayto engage a guide flange of the elevator mechanism.

FIG. 18 is schematic cross-sectional view of the elevator mechanism ofFIG. 17 showing the instrument advanced through the elevator mechanismto protrude from the endoscope at a first angle.

FIG. 19 is schematic cross-sectional view of the elevator mechanism ofFIG. 18 showing the elevator mechanism being activated to bend theinstrument with the guide flange to a second angle.

FIG. 20 is a block diagram illustrating a method of processing modularendoscope components for performing a surgical procedure.

DETAILED DESCRIPTION

FIG. 1 is a schematic diagram of endoscopy system 10 comprising imagingand control system 12 and endoscope 14. FIG. 1 an illustrative exampleof an endoscopy system suitable for use with the systems, devices andmethods described herein, such as modular endoscopy systems, modularendoscopes and methods for designing, building and deconstructingendoscopes. According to some examples, endoscope 14 can be insertableinto an anatomical region for imaging and/or to provide passage of oneor more sampling devices for biopsies, or one or more therapeuticdevices for treatment of a disease state associated with the anatomicalregion. Endoscope 14 can, in advantageous aspects, interface with andconnect to imaging and control system 12. In the illustrated example,endoscope 14 comprises a duodenoscope, though other types of endoscopescan be used with the features and teachings of the present disclosure.

Imaging and control system 12 can comprise controller 16, output unit18, input unit 20, light source 22, fluid source 24 and suction pump 26.

Imaging and control system 12 can include various ports for couplingwith endoscopy system 10. For example, controller 16 can include a datainput/output port for receiving data from and communicating data toendoscope 14. Light source 22 can include an output port fortransmitting light to endoscope 14, such as via a fiber optic link.Fluid source 24 can include a port for transmitting fluid to endoscope14. Fluid source 24 can comprise a pump and a tank of fluid or can beconnected to an external tank, vessel or storage unit. Suction pump 26can comprise a port used to draw a vacuum from endoscope 14 to generatesuction, such as for withdrawing fluid from the anatomical region intowhich endoscope 14 is inserted. Output unit 18 and input unit 20 can beused by an operator of endoscopy system 10 to control functions ofendoscopy system 10 and view output of endoscope 14. Controller 16 canadditionally be used to generate signals or other outputs from treatingthe anatomical region into which endoscope 14 is inserted. In examples,controller 16 can generate electrical output, acoustic output, a fluidoutput and the like for treating the anatomical region with, forexample, cauterizing, cutting, freezing and the like.

Endoscope 14 can comprise insertion section 28, functional section 30and handle section 32, which can be coupled to cable section 34 andcoupler section 36.

Insertion section 28 can extend distally from handle section 32 andcable section 34 can extend proximally from handle section 32. Insertionsection 28 can be elongate and include a bending section, and a distalend to which functional section 30 can be attached. The bending sectioncan be controllable (e.g., by control knob 38 on handle section 32) tomaneuver the distal end through tortuous anatomical passageways (e.g.,stomach, duodenum, kidney, ureter, etc.). Insertion section 28 can alsoinclude one or more working channels (e.g., an internal lumen) that canbe elongate and support insertion of one or more therapeutic tools offunctional section 30. The working channel can extend between handlesection 32 and functional section 30. Additional functionalities, suchas fluid passages, guide wires, and pull wires can also be provided byinsertion section 28 (e.g., via suction or irrigation passageway's, andthe like).

Handle module 32 can comprise knob 38 as well as ports 40. Knob 38 canbe coupled to a pull wire extending through insertion section 28. Ports40 can be configured to couple various electrical cables, fluid tubesand the like to handle module 32 for coupling with insertion section 28.

Imaging and control system 12, according to examples, can be provided ona mobile platform (e.g., cart 41) with shelves for housing light source22, suction pump 26, image processing unit 42, etc. Alternatively,several components of imaging and control system 12 shown in FIGS. 1 and2 can be provided directly on endoscope 14 so as to make the endoscope“self-contained.”

FIG. 2 is a schematic diagram of endoscopy system 10 of FIG. 1comprising imaging and control system 12 and endoscope 14. FIG. 2schematically illustrates components of imaging and control system 12coupled to endoscope 14, which in the illustrated example comprises aduodenoscope. Imaging and control system 12 can comprise controller 16,which can include or be coupled to image processing unit 42, treatmentgenerator 44 and drive unit 46, as well as light source 22, input unit20 and output unit 18.

Image processing unit 42 and light source 22 can each interface withendoscope 14 by wired or wireless electrical connections. Imaging andcontrol system 12 can accordingly illuminate an anatomical region,collect signals representing the anatomical region, process signalsrepresenting the anatomical region, and display images representing theanatomical region on display unit 18. Imaging and control system 12 caninclude light source 22 to illuminate the anatomical region using lightof desired spectrum (e.g., broadband white light, narrow-band imagingusing preferred electromagnetic wavelengths, and the like). Imaging andcontrol system 12 can connect (e.g., via an endoscope connector) toendoscope 14 for signal transmission (e.g., light output from lightsource, video signals from imaging system in the distal end, and thelike).

Fluid source 24 can comprise one or more sources of air, saline or otherfluids, as well as associated fluid pathways (e.g., air channels,irrigation channels, suction channels) and connectors (barb fittings,fluid seals, valves and the like). Imaging and control system 12 canalso include drive unit 46, which can be an optional component. Driveunit 46 can comprise a motorized drive for advancing a distal section ofendoscope 14, as described in at least PCT Pub. No. WO 2011/140118 A1 toFrassica et al., titled “Rotate-to-Advance Catheterization System,”which is hereby incorporated in its entirety by this reference.

FIGS. 3 and 4 illustrate a first example of functional section 30 ofendoscope 14 of FIG. 2 . FIG. 3 illustrates a top view of functionalsection 30 and FIG. 4 illustrates a cross-sectional view of functionalsection 30 taken along section plane 3-3 of FIG. 3 . FIGS. 3 and 4 eachillustrate “side-viewing endoscope” (e.g., duodenoscope) camera module50. In side-viewing endoscope camera module 50, illumination and imagingsystems are positioned such that the viewing angle of the imaging systemcorresponds to a target anatomy lateral to central longitudinal axis A1of endoscope 14.

In the example of FIGS. 3 and 4 , side-viewing endoscope camera module50 can comprise housing 52, elevator 54, fluid outlet 56, illuminationlens 58 and objective lens 60. Housing 52 can form a fluid tightcoupling with insertion section 28. Housing 52 can comprise opening forelevator 54. Elevator 54 can comprise a mechanism for moving a deviceinserted through insertion section 28. In particular, elevator 54 cancomprise a device that can bend an elongate device extended throughinsertion section 28 along axis A1. Elevator 54 can be used to bend theelongate device at an angle to axis A1 to thereby treat the anatomicalregion adjacent side-viewing endoscope camera module 50. Without regardto the detachable camera module capabilities and disposable elevatorportion constructions described herein that can be used with cameramodule 50, camera module comprises a conventional orientation ofelevator 54 relative to illumination lens 58 and objective lens 60.

As can be seen in FIG. 4 , insertion section 28 can comprise centrallumen 62 through which various components can be extended to connectfunctional section 30 with handle section 32 (FIG. 2 ). For example,illumination lens 58 can be connected to light transmitter 64, which cancomprise a fiber optic cable or cable bundle extending to light source22 (FIG. 1 ). Likewise, objective lens 60 can be coupled to prism 66 andimaging unit 67, which can be coupled to wiring 68. Also, fluid outlet56 can be coupled to fluid line 69, which can comprise a tube extendingto fluid source 24 (FIG. 1 ). Other elongate elements, e.g., tubes,wires, cables, can extend through lumen 62 to connect functional section30 with components of endoscopy system 10, such as suction pump 26 (FIG.1 ) and treatment generator 44 (FIG. 2 ).

Side-viewing endoscope camera module 50 of FIGS. 3 and 4 can includeoptical components (e.g., objective lens 60, prism 66, imaging unit 67,wiring 68) for collection of image signals, lighting components (e.g.,illumination lens 58, light transmitter 64) for transmission orgeneration of light. Endoscope camera module 50 can also include aphotosensitive element, such as a charge-coupled device (“CCD” sensor)or a complementary metal-oxide semiconductor (“CMOS”) sensor. In eitherexample, imaging unit 67 can be coupled (e.g., via wired or wirelessconnections) to image processing unit 42 (FIG. 2 ) to transmit signalsfrom the photosensitive element representing images (e.g., videosignals) to image processing unit 42, in turn to be displayed on adisplay-such as output unit 18. In various examples, imaging and controlsystem 12 and image processing unit 67 can be configured to provideoutputs at desired resolution (e.g., at least 480 p, at least 720 p, atleast 1080 p, at least 4K UHD, etc.) suitable for endoscopy procedures.

As mentioned, the present inventors have recognized that conventionalendoscopes, particularly, duodenoscopes, can include elevator sectionsthat comprise elaborate and intricate constructions that can beexpensive and difficult to clean. The present inventors have developedsolutions to these and other problems by developing endoscopes that canhave detachable, low-profile camera modules, including illuminating andimaging components, that can be separated from a disposable insertionsection sheath having an easy to produce and inexpensive elevatordesign. As such, the camera module can include high-quality orhigh-performance imaging components that can be reused and enveloped inan easy to clean housing. For example, the cameral module can include a4K, high-imaging unit that can be contained in a sealed container havingcut-outs or windows for imaging and illumination lenses, therebyeliminating or reducing cracks and crevices for biological matter tobecome lodged. Furthermore, the elevator mechanism can comprise a flat,sheet metal structure stamped and formed to attached to a disposableinsertion sheath that can be easily cleaned if desired due to simplegeometry or disposed of without significant cost due to simpleconstruction.

FIG. 5 is a schematic view of modular endoscope 100 suitable for use asendoscope 14 and with endoscope camera module 50 of FIGS. 3 and 4 .Modular endoscope 100 can comprise a modular detachable functionalmodule 102, insertion section module 104 and navigation and controlmodule 106. Modules 102, 104 and 106 can comprise components includingcustomizable features and components. As such, modular endoscope 100 canbe custom-built to perform a specific procedure for a specific patient.Individual modular components can be configured as reusable ordisposable components. Therefore, inexpensive or difficult to cleancomponents can be disposed of and expensive or easy to clean componentscan be reused after appropriate cleaning and sterilizing.

Functional module 102 can comprise functional module 30, camera module50 or other types of modules. Functional module 30 can include one orboth of an imaging device, a therapeutic device, and an ancillarytherapeutic device, as well as other devices as is described herein.Furthermore, functional module 102 can comprise camera module 162 ofendoscope 150 of FIGS. 6A and 6B and camera module 192 of endoscope 180of FIGS. 7A and 7B.

Insertion section module 104 can comprise insertion section 28, whichcan be configured to include one or more of the sheath and shaftcomponents of U.S. 63/017,901 filed on Apr. 30, 2020, titled, “InsertionSheath for Modular Endoscope with Detachable and Selectively DisposableComponents,” the entire contents of which is hereby incorporated byreference.

Navigation and control module 106 can comprise handle section 32, cablesection 34 and coupler section 36 of FIGS. 1 and 2 .

As mentioned previously, components of endoscope 14 can be modular suchthat they can be attached by an operator to initially configure thedevice for use with a patient, and can be detached by the operator afteruse with the patient. In other examples, the modular components can beassembled and disassembled by a manufacturer or a decommissioningservice without action from the operator. In an example, FIG. 5illustrates endoscope 14 of FIG. 2 , wherein components thereof areshown in a detached state. While FIG. 5 illustrates endoscope 14 asbeing constructed from three modular components (functional module 102[functional section 30]), navigation and control module 106 [handlesection 32], insertion section module 104 [insertion section 28]),additional or fewer components are contemplated, depending on thesurgical procedure to be performed with the embodiment of endoscope 14constructed or designed by the operator. Each of functional module 102,navigation and control module 106, and insertion section module 104 canbe detachable from each other. Furthermore, each of modules 102, 104 and106 can be disposed after a single clinical use. Alternatively, each ofmodules 102, 104 and 106 can be constructed using materials that wouldpermit several clinical uses. In such cases, modules 102, 104 and 106can be constructed to withstand sterilization after each clinical use.

In certain advantageous aspects, the modular construction of endoscope14 of FIGS. 2 and 5 , and as discussed herein, can permit mixing andmatching of disposable and reusable modules such that some modules canbe reused, such as expensive and/or easy to clean modules, and somemodules can be disposable, such as simple and/or difficult to cleanmodules. For example, certain modules can be detached from the endoscopeafter a clinical use for sterilization, reprocessing, and reuse forsubsequent clinical uses, while the remaining modules can be disposed.For instance, there have been concerns with inadequate reprocessing ofportions of duodenoscopes (e.g., elevator portions). As a result,single-use endoscopes that can be disposed after a single clinical use(to prevent infection between uses) have been developed. However,currently available single-use endoscopes, wherein the entire endoscopeis disposed of, can be constructed using lower cost materials resultingin a lower price for the endoscope in order to remain competitive perclinical use. In many clinical instances, lower cost materials can leadto poorer clinical performance (e.g., lower quality images, inadequatemaneuverability, insertion section module damage during insertion,poorer ergonomic of endoscope handle, etc.). As such, inferiorcomponents can result in practitioners preferring not to use suchdevices.

Accordingly, modular endoscope 14 of FIGS. 2 and 5 , and othersdescribed herein (e.g., endoscopes 150 and 18), is advantageouslyconstructed such that the end user (e.g., health care providers andfacilities) can recover certain modules of endoscope 14 for reuse, whiledisposing infection prone areas after a single clinical use. Inaddition, portions of the endoscope that are intended for reuse can beconstructed to reduce accumulation of biological materials (such as bebeing fully encapsulated), and can additionally be fluidly isolated frominfection prone areas. Such configurations promote the use of acombination of higher quality (higher cost) reusable components usableover multiple clinical uses, and lower cost, disposable portions, whilereducing infection risk, and achieving desired clinical performance. Notonly can the disposable components be constructed to include featuresonly needed for the specifically-built procedure, but the materials andconstruction can be built to only survive one-time use, both of whichhelp reduce the cost of the disposable components. For example,insertion sheaths can be built to survive the stress of only a singleoperation and does not need to be robustly constructed to surviverepetitive stresses of multiple procedures.

In examples, endoscope 100 of FIG. 5 can comprise a duodenoscope,functional module 102 can be configured as a reusable camera module,navigation and the control module 106 can comprise a reusable handlemodule, and insertion section module 104 can comprise a disposable unithaving multiple lumens. Accordingly, the camera module and thenavigation and control module can each include connectors that canmaintain each of the camera module and the navigation and control modulein an attached state to the insertion section module during use with apatient. After each use, the camera module and the navigation andcontrol module can be separated (e.g., using the connectors such asattachment mechanism 240 of FIG. 10 ), and reprocessed for subsequentuse with a new insertion section module. Conversely, the used insertionsection module can be disposed after a single use.

Additionally, the connectors of the camera module and the navigation andthe control module as well as the camera module and the navigation andthe control module can be constructed of materials and engineered toreduce any ingress of biological materials and may optionally beconstructed in a fluid-tight manner.

Modular endoscope 100 can be configured for either a “side-viewing”configuration (as shown in FIGS. 3 and 4 ) or an “end-viewing”configuration, as is conventionally known (such as a gastroscope,colonoscope, cholangioscope, etc.). In examples, wherein modularendoscope 100 is configured as a side-viewing device (e.g., side-viewingduodenoscope), the illumination unit and the imaging unit of the distalmodular section (e.g., camera module) can both be offset from alongitudinal axis (e.g., axis 174 of FIG. 6A) of the insertion sectionmodule (FIGS. 6A and 6B), or the illumination unit and the imaging unitof the distal modular section (e.g., camera module) can both be alignedwith a longitudinal axis (e.g., axis 204 of FIG. 7A) of the insertionsection module (FIGS. 7A and 7B) to facilitate a low-profile of thedevice.

FIG. 6A is a schematic view of low-profile, side-viewing endoscope 150of the present disclosure comprising illumination unit 152 and imagingunit 154 arranged in a side-by-side configuration relative to elevatorportion 156. Endoscope 150 can comprise sheath 158, elevator housing160, camera module 162 and fluid passageways 163A and 163B. Band 164 canbe disposed adjacent sheath 158 and elevator housing 160 to facilitatecoupling and sealing therebetween. Camera module 162 can be coupled toelevator housing 160 at joint line 166 using, for example, attachmentmechanism 240 of FIG. 10 .

Fluid passageways 163A and 163B can comprise tubes or conduits that canconnect nozzles 167A and 167B to fluid source 24 (FIG. 1 ) or anotherfluid source. Proximal ends of fluid passageways 163A and 163B can beconnected to air or liquid sources (e.g., fluid source 24 of FIG. 1 )for dispensing one or both of compressed air and saline or other liquidsfor cleaning functionalities, such as to remove debris or biologicalmatter from illumination unit 152 and imaging unit 154.

Fluid passageways 163A and 163B can be positioned on opposite sides ofelevator portion 156 such that nozzle 167A is directed towardillumination unit 152 and nozzle 167B is directed toward imaging unit154. Fluid passageways 163A and 163B can be disposed in a direction thatextends generally parallel to longitudinal axis 174. However, in otherconfigurations fluid passageways 163A and 163B can be disposed to directnozzles 167A and 167B in other directions. In the illustrated example,fluid passageways 163A and 163B comprise circular conduits connected tonozzles 167A and 167B. However, in other examples, fluid passageways163A and 163B can have other cross-sectional shapes and nozzles 167A and167B can have other configurations, such as jets or circular orifices.As is discussed with reference to FIG. 7A6, in other configurations, asingle fluid passageway and nozzle can be used.

FIG. 6B is a schematic cross-sectional view of endoscope 150 of FIG. 6Ataken at plane 6B-6B showing illumination unit passageway 168 andimaging unit passageway 170 located radially aside insertion passageway172. Insertion passageway 172 can extend along central axis 174 withinspace 175 of sheath 158. Illumination unit passageway 168 and imagingunit passageway 170 can extend along central axes 176 and 178,respectively, within space 175 of sheath 158.

FIG. 7A is a schematic view of low-profile, side-viewing endoscope 180of the present disclosure comprising illumination unit 182 and imagingunit 184 arranged in an end-to-end configuration relative to elevatorportion 186. Endoscope 180 can comprise sheath 188, elevator housing190, camera module 192 and fluid passageway 193. Band 194 can bedisposed adjacent sheath 188 and elevator housing 190. Camera module 192can be coupled to elevator housing 190 at joint line 196 using, forexample, attachment mechanism 240 of FIG. 10 .

Fluid passageway 193 can comprise a tube or conduit that can connectnozzle 197 to fluid source 24 (FIG. 1 ) or another fluid source.Proximal ends of fluid passageway 193 can be connected to air or liquidsources (e.g., fluid source 24 of FIG. 1 ) for dispensing one or both ofcompressed air and saline or other liquids for cleaning functionalities,such as to remove debris or biological matter from illumination unit 182and imaging unit 184. Fluid passageways 193 can be positioned on oneside of elevator portion 186 such that nozzle 197 is directed towardillumination unit 182 and imaging unit 184. Fluid passageway 193 can bedisposed in a direction that extends generally parallel to longitudinalaxis 204, with nozzle 197 being angled relative to fluid passageway 193to aim fluid or liquid toward camera module 192. However, in otherconfigurations fluid passageway 193 can be disposed to direct nozzle 197in other directions. In the illustrated example, fluid passageway 193comprises a circular conduit connected to nozzle 197. However, in otherexamples, fluid passageway 193 can have other cross-sectional shapes andnozzle 197 can have other configurations, such as a jet or circularorifice. Placement of only a single passageway (e.g., fluid passageway193)) with a single nozzle (e.g., nozzle 197) to one side of elevatorportion 186 can lead to a low-profile architecture of the distal portionin comparison to the distal portion of FIG. 6A.

FIG. 7B is a schematic cross-sectional view of endoscope 180 of FIG. 7Ataken at plane 7B-7B showing illumination unit passageway 198 andimaging unit passageway 200 located radially aligned with insertionpassageway 202. Insertion passageway 202 can extend along central axis204 within space 205 of sheath 188. Illumination unit passageway 198 andimaging unit passageway 200 can extend along central axis 206 and 208,respectively, within space 205 of sheath 188.

Endoscopes 150 and 180 of FIGS. 6A and 7A each illustrate a distal endof a low-profile endoscope having side-viewing capabilities according tothe present disclosure. As shown in FIGS. 6A and 7A, according to someembodiments, elevator portions 156 and 186 and camera modules 162 and192 can be arranged in axially in-line configurations, respectively.

For instance, with respect to endoscope 150, longitudinal axis 174 ofthe insertion section module 104 can generally pass through bothelevator portion 156 and camera module 162. In the specific example ofFIG. 6A, longitudinal axis 174 can pass between illumination unit 152and imaging unit 154. As can be seen in FIG. 6A, distal-most end surface179 can form a flat end tip that can be generally planar. For example,end surface 179 can be disposed at an angle generally perpendicular tothe longitudinal axis 174.

Likewise, with respect to endoscope 180, longitudinal axis 204 of theinsertion section module 104 can generally pass through both elevatorportion 186 and camera module 192. In the specific example of FIG. 7A,longitudinal axis 204 can pass through both illumination unit 182 andimaging unit 184. As can be seen in FIG. 7A, distal-most end surface 209can form a round end tip that can be generally non-planar. For example,end surface 209 can generally have an arcuate shape (e.g., a “bulletnose” shape), and can advantageously be atraumatic.

Accordingly, the arrangements of camera modules 162 and 192 are rotated(e.g., perpendicularly or 90° orientation) from the embodiment shown inFIGS. 3 and 4 . In either embodiment, the “axially in-line arrangement”of the camera module and the elevator portion can lead to more-efficientpackaging and a compact architecture at the distal end, and reduce theouter diameter of the distal section (e.g., in comparison to the outerdiameter of the distal end of the scope illustrated in FIGS. 3 and 4 .

FIGS. 8 and 9 illustrate enlarged sectional views of endoscope 150illustrated in FIG. 6A. Endoscope 150 can comprise illumination unit152, imaging unit 154, elevator portion 156, sheath 158, elevatorhousing 160, camera module 162, fluid passages 163A and 163B, band 164,joint line 166 and nozzles 167A and 167B.

As shown in FIG. 8 , imaging unit 154 can comprise imaging unitpassageway 170, lens 210, prism 212, photosensitive element 214 andcable 216.

As shown in FIG. 9 , illumination unit 152 can comprise illuminationunit passageway 168, lens 220 and light conductor 222.

As is discussed in greater detail with reference to FIGS. 13-15 ,elevator portion 156 can comprise elongate body 300, first end portion302, second end portion 304, arcuate section 306, guide 308 and portal310.

FIG. 8 is a schematic cross-sectional view of low-profile, side-viewingendoscope 150 of FIG. 6A taken at plane 8-8 showing imaging unit 152 andimaging unit passageway 170 relative to the elevator portion 156. Thesectional plane 8-8 passes through first axis 178 that extends throughboth imaging unit 154 and elevator portion 156 and is parallel tolongitudinal axis 174.

Imaging unit 152 can include, in examples, photosensitive element 214.According to some examples, photosensitive element 214 can be acharge-coupled device (“CCD” sensor). In alternative examples,photosensitive element 214 can be a complementary metal-oxidesemiconductor (“CMOS”) sensor. In either example, photosensitive element214 can be coupled (e.g., via wired or wireless connections) to imageprocessing unit 42 (FIG. 2 ) to transmit signals from photosensitiveelement 214 representing images (e.g., video signals) to imageprocessing unit 42, in turn to be displayed on a display (e.g., outputunit 18 of FIG. 1 ). In certain examples, imaging processing unit 42 andimaging unit 154 can be configured to provide outputs at desiredresolution (e.g., at least 480 p, at least 720 p, at least 1080 p, atleast 4K etc.) suitable for endoscopy procedures.

Imaging unit 154 can be positioned longitudinally in-line with elevatorportion 156. Elevator portion 156 can include first end portion 302 andsecond end portion 304 longitudinally spaced apart by elongate portion300. Arcuate section 306 of elongate portion 300 can position first endportion 302 and second end portion 304 in an opposing relationship suchthat each portion extends in the direction of longitudinal axis 174 andinterior space 311 is formed therebetween. Accordingly, in the exampleof FIG. 8 , imaging unit 154, including at least one lens including lens210, can be positioned adjacent arcuate section 306 and spaced apartfrom first end portion 302 and second end portion 304 of elevatorportion 156 in a direction along or parallel to longitudinal axis 174.

According to an embodiment, and with continued reference to FIGS. 6A and8 , while the illustrated examples can be suitable for a variety ofendoscopes (including side-viewing and end-viewing endoscopes), in oneexample, imaging unit 154 (positioned in-line with elevator portion 156)can be advantageously configured to permit side-viewing. Accordingly,imaging unit 154 can include optical components (e.g., lens 210, prism212, and/or optional optical fibers) to permit viewing a target regionin a direction generally non-parallel (e.g., perpendicular) tolongitudinal axis 174. FIG. 8 illustrates one example, wherein imagingunit 154 includes objective lens 210, with an optical axis 230 orientednon-parallel (e.g., perpendicular) to first axis 178 passing throughimaging unit 154 and elevator portion 156.

Referencing FIGS. 6B and 8 , the second axis 176 can be generallyparallel to longitudinal axis 174 and the first axis 178 that passesthrough elevator portion 156 and illumination unit 152. Accordingly,photosensitive element 214 can view (e.g., illustrated by imaging unitfield of view 228) a target region along a direction centered onobjective lens optical axis 230, and generally non-parallel (e.g.,perpendicular) to insertion tube longitudinal axis 174 and first axis178. In the example of FIG. 8 , one or more optical elements (e.g.,additional lenses, a roof prism) can optically couple objective lens 210to photosensitive element 214 (e.g., CCD or CMOS sensor) Photosensitiveelement 214 can be provided just below imaging lens 210 to realizeadditional space savings in the distal section of endoscope 150 and tofacilitate modular construction of camera module 162.

FIG. 9 is a schematic cross-sectional view of low-profile, side-viewingendoscope 150 of FIG. 6A taken at plane 9-9 showing illumination unit152 and illumination passageway 172 relative to elevator portion 156.Sectional plane 9-9 passes through second axis 176 that extends throughboth illumination unit 152 and elevator portion 156 and is parallel tolongitudinal axis 174 and first axis 178 (shown in FIG. 8 ).

Illumination unit 152 can comprise optical components including lens 220and other optical components and can be connected to light conductor222. Light conductor 222 can comprise optical fibers or other lightguides that can be connected to light source 22 (FIG. 2 ). As such,illumination unit 152 can be used to illuminate a target region, e.g., aregion of anatomy of a patient, with light from light source 22 vialight conductor 222. Light source 22 can be connected to a proximalportion of light conductor 22. Alternatively, in other examples,illumination unit 152 can be “self-contained.” In such self-containedunits, illumination unit 152 can include one or more light sources orlamps, such as light emitting diodes, as well as a power source such asa battery. Illumination unit 152 can be connected to a distal end oflight conductor 222. In examples, illumination unit 152 can comprise aportion of a detachable camera module as described in thecommonly-assigned U.S. patent application, 62/951,157, titled, “ModularEndoscope with Detachable and Selectively Disposable Components,” filedon Dec. 20, 2019, the entire contents of which is hereby incorporated byreference.

With reference to FIGS. 6A, 9 and 13 , illumination unit 152 can bepositioned longitudinally in-line with elevator portion 156. Elevatorportion 156 can include first end portion 302 and second end portion 304longitudinally spaced apart by elongate portion 300. Arcuate section 306of elongate portion 300 can position first end portion 302 and secondend portion 304 in an opposing relationship such that each portionextends in the direction of longitudinal axis 174 and space 311 isformed therebetween. Accordingly, in the example of FIG. 9 ,illumination unit 152, including at least one lens including lens 220,can be positioned adjacent arcuate section 306 and spaced apart fromfirst end portion 302 and second end portion 304 of elevator portion 156in a direction along or parallel to longitudinal axis 174.

According to an embodiment, and with continued reference to FIGS. 6A and9 , while the illustrated examples can be suitable for a variety ofendoscopes (including side-viewing and end-viewing endoscopes), in oneexample, illumination unit 152 (positioned in-line with elevator portion156) can be advantageously configured to permit side-viewing.Accordingly, illumination unit 152 can include optical components (e.g.,lens 220 and/or optional optical fibers) to provide light output in adirection generally non-parallel (e.g., perpendicular) to longitudinalaxis 174. FIG. 9 illustrates one example, wherein illumination unit 152includes illumination lens 220, with optical axis 224 orientednon-parallel (e.g., perpendicular) to second axis 176 passing throughthe illumination unit and the elevator portion.

Referencing FIGS. 6B and 9 , first axis 178 can be generally parallel tolongitudinal axis 174 and second axis 176. Accordingly, light from alight source, self-contained within illumination unit 152 or from lightsource 22 of FIG. 2 , can be output from the distal section of endoscope150 as a light cone 226 centered on illumination lens optical axis 224,and generally non-parallel (e.g., perpendicular) to longitudinal axis174 and second axis 176. In the example of FIG. 9 , light conductor 222can comprise one or more optical fibers (e.g., fiber bundle) that canoptically couple illumination lens 220 to the light source (e.g.,provided on light source 22 of FIG. 2 ) via illumination unit passageway168 that extends underneath elevator portion 156. Alternatively, thelight source can include light emitting diodes provided just belowillumination lens 220 to realize additional space savings in the distalsection of endoscope 150 and to facilitate modular construction ofcamera module 162.

Appreciably, referencing FIGS. 6A, 8 and 9 , second axis 176 can passthrough illumination unit 152 and elevator portion 156. Similarly, firstaxis 178 can pass through imaging unit 154 and elevator portion 156.First axis 178 and second axis 176 can each be parallel to longitudinalaxis 174. Further, referencing FIGS. 6A, 8 and 9 , illumination lensoptical axis 224 and objective lens optical axis 230 can be parallel toone another. Accordingly, illumination lens optical axis 224 andobjective lens optical axis 230 can each be non-parallel to any of firstaxis 178, second axis 176, and longitudinal axis 174. In examples,illumination lens optical axis 224 and objective lens optical axis 230can each be generally perpendicular to any of first axis 178, secondaxis 176, and longitudinal axis 174.

Embodiments of FIGS. 6A, 6B, 8 and 9 can advantageously result in areduced diameter of the distal section of the endoscope 150 incomparison to the diameter of the distal section of the endoscope 50illustrated in FIGS. 3 and 4 .

FIG. 10 illustrates attachment mechanism 240 for connecting cameramodule 162, including imaging unit 154 and illumination unit 152, toelevator housing 160, according to examples. In the illustrated example,attachment mechanism 240 is shown as coupling imaging unit 154 andillumination unit 152 simultaneously to elevator housing 160 via cameramodule 162. However, in other examples, imaging unit 154 andillumination unit 152 can be individually coupled to elevator housing160 by separate attachments mechanisms. Attachment mechanism 240 can beconfigured to allow for user detachment of camera module 162 fromelevator housing 160 (and/or other portions of insertion sheath 158).

Attachment mechanism 240 can comprise a snap engagement feature,provided by locking tab 242. Locking tab 242 can be disposed at an endof stem 244 attached to camera module 162, or illumination unit 154 orimaging unit 152 in other examples. Recess 246 can be provided on anouter surface of elevator housing 160 to form ledge 248. Recess 246 canbe sized to receive locking tab 242 and form a secure connection. Inexamples, locking tab 242 can be configured to be detached by a tool torelease locking tab 242 from recess 246 and separate camera module 162,or illumination unit 152 or imaging unit 154, from elevator housing 160.For example, stem 244 can deflect to allow locking tab 242 to slide pastrecess 246. However, stem 244 can be sufficiently resilient to holdlocking tab 242 within recess 246 unless acted upon by an externalforce, for example. Such embodiments can be suitable in instances wherea secure connection between camera module 162 (e.g., the combination ofimaging unit 154 and illumination unit 152) and elevator portion 156 isdesired during insertion. In other examples, other types of attachmentmechanism can be used in lieu of or in conjunction with attachmentmechanism 240, such as the use of fasteners with flanges, latches,threaded couplings and the like. Low-profile coupling mechanisms, suchas attachment mechanism 240, are advantageous in reducing diameter andreducing friction, which facilitates insertion into the anatomy

Endoscope 150 can further comprise couplers 250A and 250B for connectingportions of light conduit 222 at joint line 166 for wired operation ofcamera module 162. Thus, a portion of light conduit 222 distal ofcoupler 250A can connect to lens 220 and a portion of light conduit 22proximal of coupler 250B can connect to light source 22 (FIG. 1 ).Couplers 25A and 250B can comprise and suitable couplers for joiningsections of light conduit 222. In an example, couplers 250A and 250B cancomprise magnetic couplers. In other examples, ends of light conduit 222can be laid end-to-end without couplers. Imaging unit 152 canadditionally be provided with couplers similar to couplers 250A and 250Bfor cable 216. Use of such couplers, can be advantageous for use withself-contained camera modules where photosensitive element 214, wirelesscommunication device 252 and light generator 254 included within cameramodule 162. The couplers described with reference to FIG. 10 canadditionally be used with camera module 162 of FIGS. 8 and 9 , as wellas wireless communication device 252 and light generator 254.

Prior to insertion of the endoscope 150 according to some embodiments,detachable camera module 162 (including imaging unit 154 andillumination unit 152) can be attached to elevator housing 160 vialocking tab 242. Endoscope 150 can be inserted to a target region andimages of the target region can be collected. Endoscope 150 can beremoved and camera module 162 can be detached from elevator housing 160,e.g., with or without use of a tool. Camera module 162 can be sterilizedprior to reuse. Elevator housing 160, including elevator portion 156therein, and insertion sheath 158 can be disposed after use.Alternatively, elevator housing 160 and elevator portion 156 andinsertion sheath 158 can also be sterilized and reused.

FIGS. 11 and 12 illustrate a distal section of endoscope 150 accordingto another example. FIGS. 11 and 12 are generally similar to theembodiment illustrated in FIG. 7A with the addition of wide-angle lens260. In the example of FIGS. 11 and 12 , longitudinal axis 204 passesthrough each of elevator portion 186, illumination unit 182 and imagingunit 184. Imaging unit 184 can comprise imaging unit passageway 262,lens 264, prism 266, photosensitive element 268 and cable 270.Illumination unit 182 can comprise illumination unit passageway 272,lens 274 and light conductor 276. Furthermore, illumination lens opticalaxis 278 and objective lens optical axis 280 can each be generallynon-parallel (e.g., perpendicular) to longitudinal axis 204.

In the illustrated example of FIGS. 11 and 12 , illumination unit 182and imaging unit 184 can be configured to permit “wide angle”illumination and/or imaging for side-viewing endoscopes. Wide-angleimaging can permit imaging of a portion of the target anatomy situateddirectly above the elevator portion. In one embodiment, wide angleillumination and/or imaging can be accomplished by providingillumination lens 274 and/or objective lens 264 with a field of viewbetween about one-hundred-fifty degrees and about one-hundred-eightydegrees (inclusive). In examples, illumination lens 274 and objectivelens 264 can each have a field of view of about one-hundred-seventydegrees. In another example, either or both of illumination lens 274 andobjective lens 264 can be configured as a “fisheye” type lens.Accordingly, imaging unit 184 and illumination unit 182 can permit wideangle imaging and image areas that are situated above (e.g., directlyabove) elevator portion 186, such as portions immediately radiallyoutward of elevator potion 186 relative to axis 204.

FIG. 13 is a perspective view of elevator portion 156 of the presentdisclosure suitable for use with low-profile endoscopes 150 and 180, aswell as other endoscopes. Elevator portion 156 can comprise elongatebody 300, first end portion 302, second end portion 304, arcuate section306, guide 308, portal 310 and space 311. Elevator portion 156 cancomprise an elevator mechanism for deflecting an instrument extendingalong axes 174 and 204 within insertion passageways 172 and 202,respectively, as explained with reference to FIGS. 16-19 .

Elongate body 300 can comprise a unitary, generally planar sheet, asillustrated in FIGS. 14 and 15 , shaped into the geometry of FIG. 13 .First end portion 302 can be shaped to include retention features, suchas flange 312 forming shoulder 314. Second end portion 304 can comprisecoupler 316 and planar portion 318. Planar portion 318 can link secondend portion 304 with guide portion 320 and can include flared portionsnecking down width W2 of guide portion 320 down to width W1 of secondend portion 304. Guide portion 320 can be selectively widened toaccommodate features of the elevator mechanism. Guide portion 320 cancomprise guide 308 and portal 310. Guide 308 can include a chutecomprise tab or flange 322 and groove or channel 324.

First end portion 302 can be configured to be secured to the distalportion of endoscope 150, such as at sheath 158, or endoscope 180, suchas at sheath 188. In examples, flange 312 can be secured to sheath 158by pinching, crimping or any other suitable method. In additionalexamples, first end portion 302 can be provided with connectors, such asclamps and the like. As such, elevator portion 156 can be configured tobe secured to sheath 158. First end portion 302 can thus be secured toendoscope 150 by a non-rotating or non-hinged connection to fixedlyanchor elevator portion 156. In certain examples, the connection offirst end portion 302 to sheath 158 can be non-user removable, e.g.,elevator portion 156 cannot be removed from sheath 158 withoutdestructive procedures. Accordingly, first end portion 302 can besecured to the distal portion of sheath 158 at the time of manufactureand assembly and cannot be separated thereafter. Fixing of first endportion 302 can facilitate actuation of second end portion 304 to flexarcuate section 306 to activate flange 322.

Second end portion 304 can be configured to connect to an elevatoractuation mechanism. In examples, the elevator actuation mechanism caninclude a pull-wire assembly including pull wire 326 secured to handle32 (FIGS. 1 and 2 ). More specifically, pull wire 326 can be coupled toone or more actuators (e.g., knob 38 of FIG. 2 ), that can be turned byan operator (e.g., using their thumb or fingers), to control tension.Pull wire 326 can be secured to second end portion 304 at coupler 316,such as by tying or welding, etc. Pull wire 326 can transmit the tensionto second end portion 304 of elongate body 300, resulting in second endportion 304 being pulled proximally, or pushed distally, along thearrows 328 and 330 shown in FIG. 13 , respectfully. The pushing/pullingexerted on second end portion 340 of elevator portion 156 can helporient one or more endotherapy tools supported within space 311 (e.g.,at flange 322) by elevator portion 156, as is discussed with referenceto FIGS. 16-19 . Space 311 can therefor form a guide passage fordirecting endotherapy instrument 340 (FIG. 16 ) through elongate body300 to into opening 310, which can form a guide slot for directingendotherapy instrument 340 out of elongate body 300.

FIG. 14 is a top view of elongate body 300 of FIG. 13 in a flattenedstate. FIG. 15 is a side cross-sectional view of elongate body 300 ofFIG. 13 taken at plane 15-15 showing instrument guide flange 322. FIGS.14 and 15 are discussed concurrently. The sheet of elongate body 300 canhave thickness t substantially less than width W1 or length L. The sheetmay be, in some advantageous embodiments, made of stainless steel.Alternatively, other materials (alloys or non-metallic elements) arealso contemplated. Elevator portion 156 can be formed from the sheet bya variety of manufacturing techniques to result in the shape shown inFIG. 13 . In examples, elevator portion 156 can be formed by precisionstamping of the sheet into the shape shown in FIG. 14 . In an example, aflat sheet having a rectangular shape can be positioned relative to astamping machine. A die having the shape of elongate body 300 can beloaded in the stamping machine. The stamping machine can be activated topress the die against the flat sheet to thereby form elongate body 300shown in FIGS. 14 and 15 . In examples, elongate body 300 can besimultaneously stamped to form channel 324 in flange 322. Likewise,elongate body 300 can be simultaneously stamped to bend flange 322 toangle A shown in FIG. 15 and form coupler 316. In other examples, theoutline of elongate body 300, flange 322 and portal 310 can be formed byseparate stamping steps, and the shape of channel 324, the angle offlange 322 and coupler 316 can be formed by one or more subsequentsteps.

FIGS. 16-19 illustrate sectional views of elevator portion 156positioned in a distal section of side-viewing endoscope 150 accordingto any of the disclosed embodiments. Although described with referenceto endoscope 150, operation of elevator portion 156 can functionsimilarly with endoscope 180. FIGS. 16-19 can be particularly suitablewhen the side-viewing scope has an “in-line” arrangement of the elevatorportion and the camera module (e.g., such as the embodiments of FIGS. 6Aand 7A, described further in U.S. 62/958,041 filed on Jan. 7, 2020,titled, “Endoscope with a Low-Profile Distal Section,” the entirecontents of which are hereby incorporated by reference. Accordingly, theembodiments of FIGS. 16-19 can include more space further distally ofelevator portion 156 to house camera module 160. Thus, the distal tip ofelevator housing 162 shown in FIGS. 16-19 can comprise joint line 166.

With reference to FIGS. 16-19 , the distal section of endoscope 150 can,in some examples, include ramp 332. Ramp 332 can include first surface334, and second surface 336 opposite to first surface 334. First surface334 of ramp 332 can abut first end portion 302 of elongate body 300.First end portion 302 can be sandwiched between first surface 334 oframp 332 and interior surfaces of the distal section of endoscope 150during assembly. In some examples, first end portion 302 can be fixedwith respect to first surface 334 of ramp 332, or with respect tointerior surfaces of the distal section of endoscope 150. In addition,the assembly process can secure first end portion 302 and first surface334 of ramp 332 to the interior surfaces of elongate body 300 so that nogaps or other areas are present between first end portion 302, firstsurface 334 of ramp 332 and the interior surfaces of elevator portion156, to reduce or avoid ingress of biological matter. Second surface 336of ramp 332 can be generally suitable for providing initial guidance ofendotherapy instrument 340 (e.g., guidewire, catheter, or secondaryscope) as such instrument approaches the distal section in instrumentlumen 338. Second surface 336 can therefore be oriented so as to benon-parallel to first surface 334 of ramp 332. Elevator portion 156 canbe positioned such that flange 322 extends in the space available in thedistal section of endoscope 150, and flange 322 is close to or inabutment with second surface 336 of ramp 332.

With reference to FIG. 17 , flexible arcuate section 306 of elevatorportion 156 (which extends between first end portion 302 and flange 322)can at least partially be movable with respect to first end 302 and ramp332, when second end 304 of elevator portion 156 is actuated (e.g., bypull wire 326). At least portions of arcuate section 306 of elevatorportion 156 cannot directly abut or directly connect to any otherportion of the distal section of elevator portion 156, and can move inthe space surrounding arcuate section 306. Ramp 332 can be positionedproximate opening 341 on elevator housing 160. Elevator housing 160 canfurther comprise pocket 169 for storing arcuate section 306 in anun-deflected state. Opening 341 can be configured to receive endotherapyinstrument 340 from ramp 332. As can be seen in FIG. 17 , second surface336, flange 322 and opening 341 can form exit angle β relative toperpendicular of longitudinal axis 174. Thus, endotherapy instrument 340can be pushed to engage second surface 336, which can turn the distalend of endotherapy instrument 340 toward flange 322 and initially orientthe distal end of endotherapy instrument 340 at angle β.

With reference to FIG. 18 , endotherapy instrument 340 can be furtheradvanced in the direction of arrow 342 until the distal end ofendotherapy instrument 340 protrudes through opening 341. Endotherapyinstrument 340 can protrude from opening 341 at angle β1 with referenceto longitudinal axis 147. Angle β1 can be equal to angle β plusninety-degrees.

With reference to FIG. 19 , elevator portion 156 can be actuated furtherto provide additional guiding and orientation of endotherapy instrument340. For instance, elevator portion 156 can be actuated by pulling,e.g., via knobs 38 on endoscope handle 32 (FIG. 2 ), which exerts aforce on second end portion 304 of elevator portion 156 in directionshown by arrow 344 opposite to the direction of advancement arrow 342 ofendotherapy instrument 340. As second end portion 304 of elevatorportion 156 is actuated, arcuate portion 306 can rotate along thedirection indicated by arrow 346 relative to first end portion 302, andadvance the guiding portion toward instrument 340. In certainadvantageous aspects, the pulling force exerted on second end portion304 of elevator portion 156 can additionally move channel 324 proximallyin the direction of arrow 344 to catch on to instrument 340, and therebyself-seat instrument 340 in channel 324. Once seated, no relative motionbetween channel 324, flange 322 and instrument 340 can be permitted.Further actuation of elevator portion 156 (e.g., by pulling further onsecond end portion 304 of elevator portion 156) can move flange 322 andinstrument 340 seated in channel 324 in sync and adjust the angle ofinstrument 340 relative to first surface 334 of ramp 332, and withoutmoving or unseating instrument 340 from channel 324. Elevator portion156 can be actuated to position the distal end of endotherapy instrument340 at angle β2 relative to longitudinal axis 174.

Embodiments such as those of FIGS. 16-19 can be suitable for use withendoscopes that are single-use or reusable. Examples such as thosedescribed herein can also be suitable for use with endoscopes that arereusable. Unlike conventional endoscope mechanisms, elevator portion 156according to the examples illustrated herein can be easier to clean dueto the absence of several small interconnected pieces unlikeconventionally available elevator mechanisms. Accordingly, the disclosedelevator mechanisms of the present disclosure can improve procedure andpatient safety by reducing ingress of biological material (e.g.,antibiotic resistant bacteria) between uses and/or patients. Thesingle-piece construction of the elevator can reduce cost ofmanufacture.

FIG. 23 is a block diagram illustrating method 900 of processing modularendoscope components for performing a surgical procedure. At step 902, aspecific patient can be diagnosed as having a particular condition or asneeding a particular evaluation. A surgeon or other qualified medicalprofessional can perform the diagnosis.

At step 904, a particular condition of the patient can be identified asneeding interaction from a particular therapy or evaluative procedure.For example, a particular organ or anatomic region can be identified asneeding a specific intervention or evaluation.

At step 906, a particular treatment plan can be developed to address thecondition identified at step 904. The treatment plan can includeselection of a therapy to be performed, such as ablation, freezing,cauterizing, cutting, attaching and the like. The treatment plan canalso include a plan for performing a surgical technique, such asinstructions for delivering the selected therapy to the particular organor anatomic regions, such as by using a camera-enabled endoscope.

At step 908, components of a medical device to deliver the selectedtherapy can be selected. For example, a particular treatment module canbe selected to provide the selected therapy, a particular sheath orshaft can be selected to deliver the treatment module, and a particularcontrol module can be selected to control operation of the modularmedical device. Features and characteristics of the selected sheath orshaft can be selected, such as the number of delivery lumens needed toprovide the treatment, guidance and steering capabilities needed for theselected treatment plan and therapy. Likewise, a camera module can beselected to facilitate guiding of the treatment module and viewing ofthe anatomic region or organ.

At step 910, the selected components of step 908 can be assembled. Theselected components can be assembled at a medical facility where theprocedure is to be performed, at step 912A. For example, the modularcomponents can be user-assembled. In particular, a camera module can beattached using an attachment mechanism, such as a deflectable tab. Theselected components can be assembled at a manufacturing facility, atstep 912B.

At step 914, the procedure planned for at step 906 can be performed withthe medical device assembled at step 910.

At step 916, the assembled medical device used in the procedure at step914 can be disassembled. The medical device can be disassembled at themedical facility of step 912A or can be sent offsite to be disassembledat the manufacturing facility of step 912B or another repurposingfacility. The modular components can be user-disassembled by operatingan attachment mechanism.

At step 918, the disassembled components can be sorted into componentsthat can be disposed of at step 920A and components that can be reusedat step 920B.

At step 922, the disposable components can be disposed of, such as bybeing destroyed or discarded. The disposable components can comprise adisposable insertion sheath.

At step 924, the reusable components of step 920B can be cleaned andsterilized for reuse. The reusable components can comprise a detachablecamera module. As such, the cleaned and sterilized components can bereturned to inventory of the medical facility or manufacturing facilityto be used in additional procedures.

VARIOUS NOTES AND EXAMPLES

Example 1 can include or use subject matter such as an endoscope thatcan comprise a proximal section, an insertion section extendinglongitudinally from the proximal section, the insertion sectioncomprising an elongate tubular body disposed along an insertion sectionlongitudinal axis, and a lumen extending through the elongate tubularbody, and a distal section extending from the insertion section, thedistal section comprising an elevator portion comprising an elevatorconfigured to position and orient one or more endotherapy toolsextending from the lumen, and a camera module comprising an illuminationunit and an imaging unit, the camera module being positionedlongitudinally spaced apart from the elevator portion in an in-lineconfiguration, such that the insertion section longitudinal axis passesthrough the elevator portion and the camera module.

Example 2 can include, or can optionally be combined with the subjectmatter of Example 1, to optionally include an illumination unit thatcomprises an illumination lens having an illumination lens optical axisthat extends in a direction generally non-parallel to the insertionsection longitudinal axis.

Example 3 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 or 2 to optionallyinclude an imaging unit that comprises at least one objective lenscomprising an objective lens optical axis that extends in a directiongenerally non-parallel to the insertion section longitudinal axis.

Example 4 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 3 to optionallyinclude an illumination lens optical axis and an objective lens opticalaxis that extend perpendicular to the insertion section longitudinalaxis.

Example 5 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 4 to optionallyinclude an illumination unit that comprises an illumination unitpassageway disposed about a first axis, the first axis passing from theinsertion section through the elevator portion, the first axis beinggenerally parallel to the insertion section longitudinal axis.

Example 6 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 5 to optionallyinclude an imaging unit that comprises an imaging unit passagewaydisposed about a second axis, the second axis passing from the insertionsection through the elevator portion, the second axis being generallyparallel to the insertion section longitudinal axis.

Example 7 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 6 to optionallyinclude a first axis and a second axis that are offset from theinsertion section longitudinal axis in different directions relative tothe insertion section longitudinal axis.

Example 8 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 7 to optionallyinclude a first axis and a second axis that are aligned with theinsertion section longitudinal axis on one side of the insertion sectionlongitudinal axis.

Example 9 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 8 to optionallyinclude an illumination lens that has a field of view in the range ofabout 150 degrees to about 180 degrees.

Example 10 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 9 to optionallyinclude an objective lens has a field of view in the range of about 150degrees to about 180 degrees.

Example 11 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 10 to optionallyinclude an illumination unit that comprises at least one light sourcehoused within the distal section.

Example 11 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 11 to optionallyinclude an imaging unit comprises at least one photosensitive elementhoused within the distal section.

Example 13 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 12 to optionallyinclude a camera module is user-detachable from the elevator portion,and user-reattachable to the elevator portion via an attachmentmechanism.

Example 14 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 13 to optionallyinclude an the attachment mechanism comprises at least one locking tab,the locking tab configured to be received within a recess provided onthe elevator portion, the locking tab being actuatable by a user toattach or remove the camera module to from the elevator portion,respectively.

Example 15 can include or use subject matter such as an endoscope thatcan comprise a proximal section, an insertion section extendinglongitudinally from the proximal section, the insertion sectioncomprising an elongate tubular body disposed along an insertion sectionlongitudinal axis, and a lumen extending through the elongate tubularbody, and a distal section extending from the insertion section, thedistal section comprising an elevator portion comprising an elevatorconfigured to position and orient one or more endotherapy toolsextending from the lumen, and a camera module comprising an illuminationunit and an imaging unit, the camera module being user-detachable fromthe elevator portion.

Example 16 can include, or can optionally be combined with the subjectmatter of Example 15, to optionally include a camera module that ispositioned longitudinally spaced apart from the elevator portion in anin-line configuration, such that the insertion section longitudinal axispasses through the elevator portion and the camera module.

Example 17 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 15 or 16 to optionallyinclude camera module that comprises an imaging unit passageway, anobjective lens coupled to a distal end of the imaging unit passageway,an illumination unit passageway, and an illumination lens coupled to adistal end of the illumination unit passageway.

Example 18 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 17 to optionallyinclude a camera module that comprises a photosensitive element, anobjective lens coupled to the photosensitive element, a light source,and an illumination lens coupled to the light source.

Example 19 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 18 to optionallyinclude a wireless communication device.

Example 20 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 through 19 to optionallyinclude a camera module that is user-detachable from the elevatorportion via an attachment mechanism.

Example 21 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 16 through 20 to optionallyinclude an attachment mechanism that comprises at least one locking tabextending from one of the camera module or the elevator portion, and arecess provided in the other of the camera module or the elevatorportion not having the locking tab, wherein the locking tab isactuatable by a user to attach or remove the camera module from theelevator portion.

Example 22 can include or use subject matter such as a method ofprocessing modular endoscope components for performing a surgicalprocedure that can comprise identifying a specific patient to receive aspecific treatment, selecting an insertion sheath to deliver thespecific treatment, attaching a camera module to the insertion sheath,treating the specific patient with the insertion sheath having theattached camera module, and deconstructing the components of the modularendoscope into reusable and disposable components.

Example 23 can include, or can optionally be combined with the subjectmatter of Example 22, to optionally include assembling the components ofthe modular endoscope at a surgical facility.

Example 24 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 22 or 23 to optionallyinclude disposing of the disposable components, and cleaning andsanitizing the reusable components.

Example 25 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 22 through 24 to optionallyinclude disposable components that comprise the insertion sheath, andreusable components comprise the camera module.

Example 26 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 22 through 25 to optionallyinclude reusing the cleaned and sanitized reusable components in asubsequent medical procedure.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventor alsocontemplates examples in which only those elements shown or describedare provided. Moreover, the present inventor also contemplates examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

Method examples described herein can be machine or computer-implementedat least in part. Some examples can include a computer-readable mediumor machine-readable medium encoded with instructions operable toconfigure an electronic device to perform methods as described in theabove examples. An implementation of such methods can include code, suchas microcode, assembly language code, a higher-level language code, orthe like. Such code can include computer readable instructions forperforming various methods. The code may form portions of computerprogram products. Further, in an example, the code can be tangiblystored on one or more volatile, non-transitory, or non-volatile tangiblecomputer-readable media, such as during execution or at other times.Examples of these tangible computer-readable media can include, but arenot limited to, hard disks, removable magnetic disks, removable opticaldisks (e.g., compact disks and digital video disks), magnetic cassettes,memory cards or sticks, random access memories (RAMs), read onlymemories (ROMs), and the like.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

The claimed invention is:
 1. An endoscope comprising: a proximalsection; an insertion section extending longitudinally from the proximalsection, the insertion section comprising: an elongate tubular bodydisposed along an insertion section longitudinal axis; and a lumenextending through the elongate tubular body; and a distal sectionextending from the insertion section, the distal section comprising: anelevator portion comprising an elevator configured to position andorient one or more endotherapy tools extending from the lumen; and acamera module comprising an illumination unit and an imaging unit, thecamera module being positioned longitudinally spaced apart from theelevator portion in an in-line configuration, such that the elevatorportion and the camera module are axially aligned along the insertionsection longitudinal axis and the camera module is located distal of theelevator portion; wherein the camera module is user-detachable from theelevator portion such that the illumination unit and imaging unit areremovable and the elevator portion remains attached to the distalsection of the endoscope, and the camera module is user-reattachable tothe elevator portion via an attachment mechanism, wherein the attachmentmechanism comprises: at least one locking tab extending from one of thecamera module or the elevator portion; and a recess provided in theother of the camera module or the elevator portion not having thelocking tab, the recess configured to receive the at least one lockingtab; wherein the locking tab is actuatable by a user to attach or removethe camera module to/from the elevator portion.
 2. The endoscope ofclaim 1, wherein the illumination unit comprises an illumination lenshaving an illumination lens optical axis that extends in a directiongenerally non-parallel to the insertion section longitudinal axis. 3.The endoscope of claim 2, wherein the imaging unit comprises at leastone objective lens comprising an objective lens optical axis thatextends in a direction generally non-parallel to the insertion sectionlongitudinal axis.
 4. The endoscope of claim 2, wherein the illuminationlens has a field of view in the range of about 150 degrees to about 180degrees.
 5. The endoscope of claim 3, wherein the illumination lensoptical axis and the objective lens optical axis extend perpendicular tothe insertion section longitudinal axis.
 6. The endoscope of claim 3,wherein the at least one objective lens has a field of view in the rangeof about 150 degrees to about 180 degrees.
 7. The endoscope of claim 1,wherein the illumination unit comprises an illumination unit passagewaydisposed about a first axis, the first axis passing from the insertionsection through the elevator portion, the first axis being generallyparallel to the insertion section longitudinal axis.
 8. The endoscope ofclaim 7, wherein the imaging unit comprises an imaging unit passagewaydisposed about a second axis, the second axis passing from the insertionsection through the elevator portion, the second axis being generallyparallel to the insertion section longitudinal axis.
 9. The endoscope ofclaim 8, wherein the first axis and the second axis are offset from theinsertion section longitudinal axis in different directions relative tothe insertion section longitudinal axis such that the imaging unit andthe illumination unit are arranged in a side-by-side configuration atequal longitudinal positions.
 10. The endoscope of claim 8, wherein thefirst axis and the second axis are aligned with the insertion sectionlongitudinal axis on one side of the insertion section longitudinalaxis.
 11. The endoscope of claim 1, wherein the illumination unitcomprises at least one light source housed within the distal section.12. The endoscope of claim 1, wherein the imaging unit comprises atleast one photosensitive element housed within the distal section. 13.The endoscope of claim 1, wherein the illumination unit and the imagingunit are arranged in a side-by-side configuration.